Surgical Sympathetic Blockade in Heart Failure (SymBlock)

October 19, 2010 updated by: University of Sao Paulo

Left Cervico-Thoracic Sympathetic Blockade by Clipping in Systolic Heart Failure: A Randomised Controlled Trial

The investigators sought to evaluate the feasibility and safety of surgical sympathetic blockade in systolic heart failure patients and secondary to assess its cardiovascular consequences.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403000
        • Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic heart failure (at least 1 month of symptoms onset)
  • NYHA functional class II or III
  • LV ejection fraction 40% or lower
  • resting heart rate higher than 65 bpm
  • either maximum beta-blocker therapy according to guidelines or no beta-blocker use for intolerance.

Exclusion Criteria:

  • NYHA functional class I or IV
  • cardiogenic shock
  • resting heart rate ≤ 65 bpm
  • systolic blood pressure < 90 mmHg
  • sustained ventricular tachycardia
  • eligibility to other surgical procedures
  • procedure-limiting comorbidity
  • presence of ICD or pacemaker
  • valvar, chagasic or congenital cardiomyopathy
  • age > 70 years
  • patient refusal
  • contra-indication to videothoracoscopy
  • decompensated thyroid disease
  • atrial fibrillation or flutter
  • active infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Surgery
Procedure: Left cervico-thoracic sympathetic blockade
Left cervico-thoracic sympathetic blockade by videothoracoscopic clipping under general anesthesia and single-lumen orotracheal intubation in semi-sitting position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative mortality and morbidity
Time Frame: 30 days after operation

Study interruption criteria:

  • death attributable to surgical procedure;
  • cardiogenic shock attributable to surgical procedure;
  • worsening of heart failure symptoms attributable to surgical procedure;
  • Horner's syndrome
  • hypotension or bradiarrhythmia attributable to surgical procedure
30 days after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular effects
Time Frame: 6 months
  • left ventricle ejection fraction (echo and gated blood pool)
  • end left ventricle diastolic diameter
  • mean heart rate
  • heart rate variability
  • New York Heart Association functional class
  • Minesotta Living with Heart Failure Questionnaire Score
  • peak oxygen consumption
  • walked distance in 6 minute walking test
  • BNP
  • 123-I-Metaiodobenzylguanidine (late heart/mediastinum ratio)
  • sympathetic peripheral nerve activity (microneurography)
  • baroreflex parameters (low and high frequency)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Study Chair: Edimar A Bocchi, MD, Heart Institute (InCor) HC FMUSP
  • Principal Investigator: Paulo M Pego-Fernandes, MD, Heart Institute (InCor) HC FMUSP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

October 18, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (Estimate)

October 20, 2010

Study Record Updates

Last Update Posted (Estimate)

October 20, 2010

Last Update Submitted That Met QC Criteria

October 19, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SymBlock Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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